Quality Control » Page 5 of 5

Injectable | Parenteral | Sterile Preparations, types, Standard test

Injectable preparations, also known as parenteral preparations, are sterile formulations used for parenteral infusion or implantation. They are administered by injection to maintain sterility and prevent contamination by foreign matter, pyrogens, microorganisms, and bacterial endotoxins. These preparations must be made using methods that ensure sterility. Water for injection (WFI) is commonly used as a vehicle … Read more

Tablet Friability Test Calibration and Specification

The Friability test helps measure the powder lost from tablet surfaces during handling and transport. This test is typically done on uncoated tablets. The parallel to friability test, tablets hardness, is also tested to know the strength of tablets which is more important for drugs to withstand throw-out their lifecycle. However, hardness is not only a parameter … Read more

Pharmaceutical Sampling, types, tools ( Guidelines)

Pharmaceutical Sampling involves selecting a portion of a product for a specific purpose. The sample is a part of a material collected following a defined sampling procedure. A Sampling plan specifies the location, the number of units, the quantity of material to collect, and the associated acceptance criteria. The Sampling procedure contains all sampling operations … Read more

MACO and NOEL Calculation for Cleaning Validation

MACO and NOEL calculations have great importance in the pharmaceutical industries. NOEL refers to “No observed effect level” and MACO is a “Maximum allowable carryover”. NOEL is used to determine MACO during cleaning validation. NOEL Calculation: NEOL is calculated by using LD50 and average. Adult dose. LD50 is a lethal dose (it may vary), considered an adult’s … Read more

Vernier Caliper measurement and operation in Pharma

Vernier caliper is used widely in pharmaceutical and other industries for Accurate Measurement of any products and part of the equipment is essential to know the actual dimension. So to measure the dimension first you have to know about, the vernier caliper Definition, procedure, parts, operation, cleaning, error solutions, and purpose. Vernier Caliper Definition: The Dial … Read more

Handling of Laboratory Incident in Pharma

Laboratory Incident Definition: Any unintentional or unexpected event occurring during, discovered within, or arising after analysis that may adversely impact the quality of data and the resulting outcomes. Types of Common Laboratory Incidents: Below are the different common types of lab incidents in the pharmaceutical field that often occur. Type of Lab incident: Laboratory incidents … Read more

Calibration of UV-visible spectrophotometer

calibration UV-visible spectrophotometer

UV-visible spectrophotometer are widely used in the pharmaceutical industry for analyzing and quantifying various drug substances. It is important to ensure that these instruments are calibrated accurately and regularly to obtain reliable and accurate results. In this guide, we will take you through the calibration procedure and parameters of a UV spectrophotometer. Calibration of UV-visible … Read more

User Requirement Specification (URS) in Pharmaceutical

User requirement specification (URS) is a list of all the equipment-related requirements from the user, The list shall be prepared based on the types of equipment to be purchased. After the preparation of the list, the URS documents are sent to the manufacturer to get the required materials as per the given criteria. The user department … Read more

Autoclave Validation | Study on temperature Probes

Autoclave validation is required to get effective Sterilization to ensure good product quality and also sterility of glassware and media used for analysis is very important for product manufacturing. Ineffective autoclave validation may cause deviation in sterility and it may lead to a false result. So data loggers play a very important role in recording the … Read more

Disintegration Test Apparatus: Diagram, Principle, Types, Procedure, Calibration, Limit and Assembly

Labeled diagram of a pharmaceutical dissolution test apparatus showing the display unit, stirring arms, baskets, vessels, water bath, and temperature probe.

A disintegration test apparatus: a brief explanation of the diagram and main elements, as well as the mechanism of the disintegration process itself. Moreover, the present article describes apparatus types, discusses the disintegration test procedure, calibration requirements, and time limits according to USP, BP, IP, and Ph. Eur. – useful information for quality control analysts, production managers, and students who study the characteristics of medicinal forms and want to determine the disintegration time of tablets or capsules.